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Not Yet RecruitingNCT07042932

Online Physical Activity and Health Counseling for Survivors of Childhood Acute Lymphoblastic Leukemia

Online Physical Activity and Health Counseling for Survivors of Childhood Acute Lymphoblastic Leukemia (OPAC-ALL)

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
82 (estimated)
Sponsor
Rigshospitalet, Denmark · Academic / Other
Sex
All
Age
10 Years – 21 Years
Healthy volunteers
Not accepted

Summary

Advances in the medical treatment of childhood acute lymphoblastic leukemia (ALL) have resulted in 5-year survival rates above 90%- however, the success is not without consequences. Childhood ALL survivors experience markedly impaired physical capacity - reducing their opportunity to engage in everyday activities including leisure activities, sports, and school - affecting their quality of life. Furthermore, Childhood ALL survivors have markedly increased risk of chronic medical conditions including cardiometabolic diseases - that can be prevented through an active lifestyle. Thus, it is imperative to develop novel interventions that can mitigate these treatment-related late-effects. In this RCT, including 82 childhood ALL survivors (10-21 years-old), we will investigate a 26-week online exercise intervention combined with access to a lifestyle physical activity webpage, and health consultations on cardiorespiratory fitness (primary outcome) markers of metabolic syndrome, and physical activity habits. While other pilot studies have investigated the effects of exercise for childhood ALL survivors, this study is the first RCT internationally to investigate the effects of online exercise combined with education through an app and health counselling for childhood ALL survivor. Using this approach, we are geographically able to reach every survivor in our targeted population, thereby, minimizing logistic challenges like travel distances. This study has the potential to radically change the way physical rehabilitation is approached in childhood ALL survivors - Potentially changing the workflow of health professionals from referring only survivors with specific deficits to local physiotherapy to referring all survivors to an exercise program tailored to their needs. By improving the children's general physical capacity, we can give the children the required tools to re-enter everyday life activities, including school physical education, leisure activities, and sports earlier after treatment has ended - ultimately minimizing the social complications of treatment. This study will also answer the government´s call to digitalize 30% of rehabilitation by the 2030.

Conditions

Interventions

TypeNameDescription
OTHERExercise26 weeks online high intensity functional training, performed 1-2 times per week + access to a LIFESTYLE PHYSICAL ACTIVITY WEBSITE including 8 modules; 1) Welcome, information about the intervention and the aims of the study, 2) Living a physically active lifestyle, 3) Sedentary behavior, 4) General exercise recommendations, 5) How to stay motivated, 6) Strength training, 7) flexibility, balance, and coordination, and 8) Healthy eating + weekly motivational counseling

Timeline

Start date
2025-07-01
Primary completion
2029-12-31
Completion
2030-12-31
First posted
2025-06-29
Last updated
2025-06-29

Source: ClinicalTrials.gov record NCT07042932. Inclusion in this directory is not an endorsement.